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Author Elyse Seltzer

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Pharmacokinetics of UGN-101, a mitomycin-containing reverse thermal gel instilled via retrograde catheter for the treatment of low-grade upper tract urothelial carcinoma.

Ahmad Shabsigh, Nir Kleinmann, Angela B Smith, Douglas Scherr, Elyse Seltzer, Mark Schoenberg, Seth P Lerner,

<h4>Purpose</h4>To evaluate the pharmacokinetic properties of UGN-101, a mitomycin-containing reverse thermal gel used as primary chemoablative treatment for low-grade upper tract urothelial carcinoma (UTUC), in a subset of patients participating in a phase 3 clinical trial.<h4>Methods</h4>Pharmacokinetic parameters (C<sub>max</sub>, T<sub>max</sub>, AUC<sub>(0-6)</sub>, λz, t<sub>½</sub>, and AUC<sub>inf</sub>) were evaluated in six participants (male ... Read more >>

Cancer Chemother Pharmacol (Cancer chemotherapy and pharmacology)
[2021, 87(6):799-805]

Cited: 0 times

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Complications Associated With Ureteroscopic Management of Upper Tract Urothelial Carcinoma.

Jennifer Linehan, Mark Schoenberg, Elyse Seltzer, Kim Thacker, Angela B Smith,

<h4>Objectives</h4>To compile and examine safety data from clinical studies of endoscopic management of patients with low-grade upper tract urothelial carcinoma (UTUC) to identify rates and factors associated with reported complications.<h4>Methods</h4>Ovid Medline and Ovid Medline Daily (with Embase as secondary search) including citations from 1946-2018 were queried using the following terms: ... Read more >>

Urology (Urology)
[2021, 147:87-95]

Cited: 0 times

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Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial.

Nir Kleinmann, Surena F Matin, Phillip M Pierorazio, John L Gore, Ahmad Shabsigh, Brian Hu, Karim Chamie, Guilherme Godoy, Scott Hubosky, Marcelino Rivera, Michael O'Donnell, Marcus Quek, Jay D Raman, John J Knoedler, Douglas Scherr, Joshua Stern, Christopher Weight, Alon Weizer, Michael Woods, Hristos Kaimakliotis, Angela B Smith, Jennifer Linehan, Jonathan Coleman, Mitchell R Humphreys, Raymond Pak, David Lifshitz, Michael Verni, Mehrad Adibi, Mahul B Amin, Elyse Seltzer, Ifat Klein, Marina Konorty, Dalit Strauss-Ayali, Gil Hakim, Mark Schoenberg, Seth P Lerner,

<h4>Background</h4>Most patients with low-grade upper tract urothelial cancer are treated by radical nephroureterectomy. We aimed to assess the safety and activity of a non-surgical treatment using instillation of UGN-101, a mitomycin-containing reverse thermal gel.<h4>Methods</h4>In this open-label, single-arm, phase 3 trial, participants were recruited from 24 academic sites in the USA ... Read more >>

Lancet Oncol (The Lancet. Oncology)
[2020, 21(6):776-785]

Cited: 6 times

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Erratum to: Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial.

Thomas M File, Lisa Goldberg, Anita Das, Carolyn Sweeney, John Saviski, Steven P Gelone, Elyse Seltzer, Susanne Paukner, Wolfgang W Wicha, George H Talbot, Leanne B Gasink,

Clin Infect Dis (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America)
[2020, 70(11):2459]

Cited: 1 time

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Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial.

Thomas M File, Lisa Goldberg, Anita Das, Carolyn Sweeney, John Saviski, Steven P Gelone, Elyse Seltzer, Susanne Paukner, Wolfgang W Wicha, George H Talbot, Leanne B Gasink,

<h4>Background</h4>Lefamulin, a pleuromutilin antibiotic, is active against pathogens commonly causing community-acquired bacterial pneumonia (CABP). The Lefamulin Evaluation Against Pneumonia (LEAP 1) study was a global noninferiority trial to evaluate the efficacy and safety of lefamulin for the treatment of CABP.<h4>Methods</h4>In this double-blind study, adults with CABP of Pneumonia Outcomes Research ... Read more >>

Clin Infect Dis (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America)
[2019, 69(11):1856-1867]

Cited: 27 times

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2386. Efficacy of Lefamulin (LEF) vs. Moxifloxacin (MOX) Against Common Pathogens in Adults With Community-Acquired Bacterial Pneumonia (CABP): Results From the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

Thomas File, Lisa Goldberg, Susanne Paukner, Anita Das, Steven P Gelone, John Saviski, Carolyn Sweeney, Elyse Seltzer, George H Talbot, Leanne B Gasink,

Abstract <h4>Background</h4> New CABP treatments with targeted activity and improved tolerability are needed. LEF, a novel pleuromutilin antibiotic that binds to a conserved region of the bacterial ribosome, is in development for IV or oral CABP treatment. This Phase 3 clinical study evaluated the efficacy of LEF vs. MOX in ... Read more >>

Open Forum Infect Dis (Open forum infectious diseases)
[2018, 5(Suppl 1):S711-S712]

Cited: 0 times

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Pharmacokinetics of dalbavancin in patients with renal or hepatic impairment.

Thomas Marbury, James A Dowell, Elyse Seltzer, Mary Buckwalter,

Three open-label studies assessed the safety, tolerability, and pharmacokinetics of intravenous dalbavancin in patients with hepatic or renal impairment, including patients with end-stage renal disease (ESRD) receiving dialysis. In each study, 4 to 10 patients with mild, moderate, or severe impairment and age-, sex-, and weight-matched controls were administered either ... Read more >>

J Clin Pharmacol (Journal of clinical pharmacology)
[2009, 49(4):465-476]

Cited: 28 times

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Pharmacokinetics of dalbavancin in plasma and skin blister fluid.

David P Nicolau, Heather K Sun, Elyse Seltzer, Mary Buckwalter, James A Dowell,

<h4>Objectives</h4>Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria. The aim of the present study was to assess the penetration of dalbavancin into skin blister fluid.<h4>Methods</h4>Nine healthy subjects (five males; ranging in age from 26 to ... Read more >>

J Antimicrob Chemother (The Journal of antimicrobial chemotherapy)
[2007, 60(3):681-684]

Cited: 28 times

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Randomized, double-blind comparison of once-weekly dalbavancin versus twice-daily linezolid therapy for the treatment of complicated skin and skin structure infections.

Luis E Jauregui, Simon Babazadeh, Elyse Seltzer, Lisa Goldberg, Dainis Krievins, Mark Frederick, David Krause, Igors Satilovs, Zilvinas Endzinas, Jeffrey Breaux, William O'Riordan,

<h4>Background</h4>Dalbavancin, a novel lipoglycopeptide with a pharmacokinetic profile that allows weekly dosing, is active against gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The efficacy of dalbavancin for treatment of skin and skin structure infections (SSSIs) was demonstrated in a phase 2 study.<h4>Methods</h4>In a phase 3 noninferiority study, patients with complicated ... Read more >>

Clin Infect Dis (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America)
[2005, 41(10):1407-1415]

Cited: 164 times

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Efficacy and safety of weekly dalbavancin therapy for catheter-related bloodstream infection caused by gram-positive pathogens.

Issam Raad, Rabih Darouiche, Jose Vazquez, Arnold Lentnek, Ray Hachem, Hend Hanna, Beth Goldstein, Tim Henkel, Elyse Seltzer,

<h4>Background</h4>Catheter-related bloodstream infections (CR-BSIs) are associated with substantial mortality, prolongation of hospital stay, and increased cost of care. Dalbavancin, a new glycopeptide antibiotic with unique pharmacokinetic properties that have allowed clinical development of a weekly dosing regimen, possesses excellent activity against clinically important gram-positive bacteria, suggesting utility in the treatment ... Read more >>

Clin Infect Dis (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America)
[2005, 40(3):374-380]

Cited: 131 times

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Once-weekly dalbavancin versus standard-of-care antimicrobial regimens for treatment of skin and soft-tissue infections.

Elyse Seltzer, Mary Beth Dorr, Beth P Goldstein, Marc Perry, James A Dowell, Tim Henkel, ,

Dalbavancin, a novel glycopeptide with a long elimination half-life ( approximately 9-12 days), was compared to standard antimicrobial therapy for skin and soft-tissue infections (SSTIs). In a randomized, controlled, open-label, phase 2 proof-of-concept trial, adults received 1100 mg of dalbavancin (as a single intravenous infusion), 1000 mg of dalbavancin intravenously ... Read more >>

Clin Infect Dis (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America)
[2003, 37(10):1298-1303]

Cited: 125 times

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Short treatment durations for acute bacterial rhinosinusitis: Five days of gemifloxacin versus 7 days of gemifloxacin.

Berrylin J Ferguson, Jack Anon, Michael D Poole, Kim Hendrick, Martyn Gilson, Elyse G Seltzer, ,

<h4>Objective</h4>The primary objective of this study was to demonstrate the clinical and radiologic efficacy of 5 days compared with 7 days of gemifloxacin therapy in the treatment of acute bacterial rhinosinusitis (ABRS).<h4>Study design</h4>In this prospective, double-blind, multicenter, parallel-group study, adult patients presenting with ABRS were randomized to receive gemifloxacin 320 ... Read more >>

Otolaryngol Head Neck Surg (Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery)
[2002, 127(1):1-6]

Cited: 8 times

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